CADTH CDEC FINAL RECOMMENDATION
|
|
- Judith Hoover
- 6 years ago
- Views:
Transcription
1 CADTH CDEC FINAL RECOMMENDATION NINTEDANIB (Ofev Boehringer Ingelheim Canada Ltd.) Indication: Idiopathic Pulmonary Fibrosis Recommendation: The CADTH Canadian Drug Expert Committee (CDEC) recommends that nintedanib be listed for the treatment of idiopathic pulmonary fibrosis (IPF), if the following clinical criteria and conditions are met: Clinical Criteria: Forced vital capacity (FVC) greater than or equal to 50% of predicted. Treatment with nintedanib should be discontinued if absolute FVC declines by 10% within any 12-month period while receiving therapy. Conditions: Under the care of a specialist with experience in the diagnosis and management of IPF. Drug plan cost for nintedanib must not exceed the drug plan cost for pirfenidone. Reasons for the Recommendation: 1. Two double-blind, randomized controlled trials (RCTs) (INPULSIS-1 [N = 515] and INPULSIS-2 [N = 551]) demonstrated that nintedanib 150 mg twice daily resulted in statistically significant improvements in FVC compared with placebo. 2. At the submitted price ($27.18 per 100 mg tablet and $54.36 per 150 mg tablet), the annual cost of treatment with nintedanib ($39,683 per year) is less than the cost of treatment with pirfenidone ($41,983 in the first year and $42,804 in subsequent years). Of Note: CDEC noted the following: Nintedanib should not be used in combination with pirfenidone. There is no evidence addressing the use of nintedanib in patients who have failed treatment with pirfenidone; therefore, CDEC was unable to make a recommendation addressing this patient population. All other causes of restrictive lung disease (e.g., collagen vascular disorders or hypersensitivity pneumonitis) should be excluded before initiating treatment. Notice of Final Recommendation October 15, 2015 Page 1 of 7
2 Background: Nintedanib is an inhibitor of multiple tyrosine kinases, including fibroblast growth factor receptor 1-3, platelet-derived growth factor alpha and beta, and vascular endothelial growth factor receptor 1-3. Nintedanib is indicated for the treatment of IPF and is available as 100 mg and 150 mg oral capsules. The recommended dose is 150 mg twice daily, administered approximately 12 hours apart with food. Summary of CDEC Considerations: CDEC considered the following information prepared by the CADTH (CDR): a systematic review of RCTs and pivotal studies of nintedanib, a critique of the manufacturer s pharmacoeconomic evaluation, and patient group submitted information about outcomes and issues important to patients with IPF. Patient Input Information Four patient groups provided their perspectives: The Lung Association of Saskatchewan, The Ontario Lung Association, The Canadian Pulmonary Fibrosis Foundation, and The British Columbia Lung Association and Lung Groups. Surveys conducted in 2015 and 2014 were used by two groups to collect perspectives of patients with IPF and caregivers, including a total of 28 respondents who had used nintedanib. Other associations drew on the expertise of staff with direct and regular contact with IPF patients. The following is a summary of information provided by the four patient groups: IPF is a progressive and life-threatening condition that has no cure. Patients with IPF often experience breathlessness, fatigue, loss of energy, reduced physical activity, and a chronic cough. Additional symptoms can also include chest pain or tightness, rapid weight loss, leg swelling, wheezing, and difficulty fighting infections. In addition to the symptoms, patients and caregivers have to manage psychosocial issues associated with IPF. The stress of the diagnosis and prognosis greatly affects patients quality of life and mental well-being, even among those with mild disease and minimal symptoms. There are few supportive treatments available to manage symptoms of IPF. Patients have reported using oxygen, N-acetylcysteine, prednisone, azathioprine, and pulmonary rehabilitation. These treatments were somewhat effective in some patients but the drug therapies were often accompanied by unwanted side effects (such as weight gain, mood swings, confusion, difficulty sleeping, and bowel issues) that added to their stress. Patients realize that nintedanib is not a cure for IPF and hope that it may offer them an alternate medication choice, with potentially increased tolerability, if current treatment is not well tolerated. Patients are also hopeful that nintedanib will slow the progression of IPF and, at least partially, address their most problematic symptoms. Patients are willing to cope with side effects as long as they are not worse than what they are currently experiencing, and are not irreversible. Clinical Trials The CDR systematic review included two 52-week, placebo-controlled, double-blind, phase 3 RCTs: INPULSIS-1 (N = 515) and INPULSIS-2 (N = 551). Patients were randomized (3:2) to receive nintedanib 150 mg twice daily or placebo. In the case of adverse events, the dosage of nintedanib could be reduced to 100 mg twice daily at the request of the investigator. Both trials enrolled patients who were at least 40 years of age with a diagnosis of IPF within the past five Notice of Final Recommendation October 15, 2015 Page 2 of 7
3 years according to the most recent American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines with baseline FVC 50% predicted and carbon monoxide diffusion capacity (DLCO) of 30% to 79% predicted. Outcomes Outcomes were defined a priori in the CDR systematic review protocol. Of these, CDEC discussed the following: Mortality evaluated using survival analyses for time to death, time to death due to respiratory cause (adjudicated), and time to on-treatment death. Lung-transplantation or death A patient was considered to qualify for a lung transplant if that patient had FVC < 45% predicted or DLCO < 30% predicted or oxygen saturation of peripheral blood (SpO 2 ) < 88% at rest. Transplantation was evaluated as composite outcomes using survival analyses for time to death or lung transplant and time to death or lung transplant or qualifying for lung transplant, all over 52 weeks. FVC volume of air that can be forcibly exhaled from the lungs after taking in the deepest breath possible. FVC was evaluated using the following measures: Annual rate of decline in FVC Absolute change from baseline in FVC Absolute change from baseline in per cent predicted FVC Proportion of patients with an absolute decline in per cent predicted FVC of no greater than 5% or 10% and with an FVC evaluation at 52 weeks. St. George s Respiratory Questionnaire (SGRQ) a self-administered 50-item instrument used to assess impaired health and perceived well-being in respiratory disease. The SGRQ is divided into three dimensions: symptoms, activity, and impacts. Total SGRQ scores range from 0 to 100, with higher values indicating lower health-related quality of life. A minimal clinically important difference in the SGRQ total score in IPF has been reported to be 6 to 13. The SGRQ was evaluated using the following measures: Change from baseline in domain scores and total score Proportion of SGRQ responders (defined as absolute change from baseline at 52 weeks in SGRQ total score 4 points) Change from baseline in an IPF-specific version of the SGRQ (SGRQ-I) total score. The primary efficacy end point in both INPULSIS trials was the adjusted rate of decline in FVC over 52 weeks. The two key secondary end points were the change from baseline to 52 weeks in the SGRQ total score and the time to first investigator-reported acute IPF exacerbation. Efficacy There were no statistically significant differences between nintedanib and placebo for time to death, time to death due to respiratory cause, time to on-treatment death, time to death or lung transplant, and time to death or lung transplant or qualifying for lung transplant. The hazard ratios from the pooled analyses of INPULSIS-1 and INPULSIS-2 were: Time to death: 0.70 (95% confidence interval [CI], 0.43 to 1.12); P = Time to death due to respiratory cause: 0.74 (95% CI, 0.41 to 1.34); P = Time to on-treatment death: 0.68 (95% CI, 0.39 to 1.19); P = Time to death or lung transplant: 0.70 (95% CI, 0.44 to 1.10); P = Time to death or lung transplant or qualifying for lung transplant: 0.80 (95% CI, 0.60 to 1.06); P = Notice of Final Recommendation October 15, 2015 Page 3 of 7
4 The adjusted rate of decline in FVC over 52 weeks was statistically significantly lower in the nintedanib groups compared with the placebo groups in both trials. The adjusted rate differences were: INPULSIS-1: ml per year (95% CI, to ); P < INPULSIS-2: ml per year (95% CI, to ); P = Pooled: ml per year (95% CI, to ); P < The absolute change from baseline in FVC and in FVC per cent predicted over 52 weeks was statistically significantly lower in the nintedanib-treated groups compared with the placebo-treated groups in both INPULSIS-1 and INPULSIS-2. The adjusted mean differences in FVC and per cent predicted FVC (respectively) were: INPULSIS-1: ml (95% CI, to ) and 3.22 (95% CI, 2.11 to 4.33) INPULSIS-2: ml (95% CI, to ) and 3.06 (95% CI, 1.87 to 4.25). In both INPULSIS trials, a statistically significantly greater proportion of nintedanib-treated patients (52.75% and 53.19%) had a decline in FVC of 5% compared with placebo-treated patients (38.24% and 39.27%). A statistically significant difference was also observed for the proportion of patients with a decline in FVC of 10% in INPULSIS-1; however, there was no significant difference in INPULSIS-2. The odds ratios for achieving a decline of 5% or 10% in FVC, respectively, were: INPULSIS-1: 1.85 (95% CI, 1.28 to 2.66) and (95% CI, 1.32 to 2.79) INPULSIS-2: 1.79 (95% CI, 1.26 to 2.55) and (95% CI, 0.89 to 1.86). In INPULSIS-2, there was a statistically significant difference between nintedanib and placebo in the total SGRQ score; however, there was no statistically significant difference in INPULSIS-1 and in the pooled analysis. The differences in adjusted mean change from baseline to week 52 were: INPULSIS-1: 0.05 (95% CI, 2.50 to 2.40); P = INPULSIS-2: 2.69 (95% CI, 4.95 to 0.43); P = Pooled: 1.43 (95% CI, 3.09 to 0.23); P = In INPULSIS-2, there was a statistically significant decrease in the time to the first acute exacerbation (investigator-reported) in the nintedanib group compared with the placebo group; however, there was no statistically significant difference in INPULSIS-1 or in the pooled analysis: INPULSIS-1: 1.15 (95% CI, 0.54 to 2.42); P = INPULSIS-2: 0.38 (95% CI, 0.19 to 0.77); P = Pooled: 0.64 (95% CI, 0.39 to 1.05); P = The proportion of patients who received a lung transplant was low across all treatment groups in the INPULSIS trials (i.e., 0% to 1.3% with nintedanib and 0.5% to 0.9% with placebo). Patients identified symptoms and the severity of symptoms as important outcomes for IPF. There were no statistically significant differences observed between treatment groups in any of the patient-report outcomes used to measure symptoms in either INPULSIS-1 or INPULSIS-2. Notice of Final Recommendation October 15, 2015 Page 4 of 7
5 Harms (Safety and Tolerability) Across both treatment groups, the most frequent serious adverse event in both the nintedanib and placebo groups was IPF. The proportions of patients who experienced at least one serious adverse event were: INPULSIS-1: 31.1% with nintedanib and 27.0% with placebo INPULSIS-2: 29.8% with nintedanib and 32.9% with placebo. The most frequently reported adverse event in the nintedanib groups was diarrhea (61.5% and 63.2%) when compared with the placebo groups (18.6% and 18.3%). Similarly, other gastrointestinal adverse events (e.g., nausea, decreased appetite, vomiting, and weight loss) occurred more frequently with nintedanib. The proportions of patients who experienced at least one adverse event were: INPULSIS-1: 96.4% with nintedanib and 88.7% with placebo INPULSIS-2: 94.5% with nintedanib and 90.4% with placebo. The proportions of patients who withdrew as a result of adverse events were: INPULSIS-1: 21.0% with nintedanib and 10.8% with placebo INPULSIS-2: 17.6% with nintedanib and 15.1% with placebo. Cost and Cost-Effectiveness The manufacturer submitted a cost-utility analysis comparing nintedanib plus best supportive care (BSC) versus BSC alone. BSC included patient monitoring, oxygen, and concomitant therapies (e.g., proton pump inhibitors, bronchodilators, and antitussive treatments) and was assumed to be represented by the control groups of the INPULSIS trials. Comparisons with pirfenidone and N-acetylcysteine in adult patients with IPF were also performed over a lifetime horizon (approximately 30 years) from a public-payer perspective. The risks of death, exacerbations, and loss of lung function for patients receiving BSC were obtained from the TOMORROW and INPULSIS trials, and mathematical models were used to estimate long-term efficacy. A manufacturer-conducted network meta-analysis (NMA) was used to estimate relative efficacy and harms among treatments. Quality of life was assigned for each per cent predicted FVC category by compiling data from the INPULSIS trials. CDR identified a number of limitations with the manufacturer s pharmacoeconomic submission: One-year clinical trial data from the BSC groups were modelled over a lifetime horizon (~30 years). While best fit was assessed during this one-year period, and face validity was assessed by comparing modelled survival with observational data, alternate parametric models led to significant differences in survival. The reference case model used the point estimate of survival, which was not statistically significant in either the clinical trials or the NMA. The manufacturer assumed that differences in outcomes that were observed in short-term RCTs (e.g., 12 months) can be extrapolated to a lifetime horizon. In the base case, the manufacturer reported that nintedanib compared with BSC results in an incremental cost-utility ratio (ICUR) of $248,186 per quality-adjusted life-year (QALY). When compared with pirfenidone, nintedanib dominates pirfenidone due to a lower drug acquisition cost (i.e., $9 less per day). The ICURs in the CDR reference case increase dramatically when direct evidence is used to inform the model, and when nintedanib is assumed to result in similar survival compared with BSC ($315,000 to $1,300,000 per QALY). There is limited comparative Notice of Final Recommendation October 15, 2015 Page 5 of 7
6 clinical information for nintedanib and pirfenidone and there is significant uncertainty in the model, particularly with the long-term risk of death. At the recommended daily dose of nintedanib (150 mg twice daily), nintedanib ($109 per day) is less costly than pirfenidone ($117 per day); therefore, when comparing only drug costs, treatment with nintedanib results in modest cost savings compared with pirfenidone. Other Discussion Points: CDEC noted the following: Nintedanib and pirfenidone have different mechanisms of action; however, there is no evidence evaluating the efficacy and safety of their combined usage. There is potential for these two products to be used in combination, which could be associated with significant costs for the CDR-participating drug plans. Two indirect comparisons suggested similar efficacy between nintedanib and pirfenidone; however, due to heterogeneity across the included RCTs, CDEC concluded that there remains uncertainty regarding the comparative safety and efficacy for these two treatments. The two INPULSIS trials did not exclude people with normal lung function, while the ASCEND trial comparing pirfenidone against placebo imposed an upper limit on FVC. This resulted in a clinically meaningful difference in baseline per cent predicted FVC between the INPULSIS and ASCEND trials and suggested that patients in ASCEND may have had more advanced disease. This difference in baseline disease severity may have influenced the number of mortality events in the trials and impacted the ability to observe a mortality benefit with nintedanib. The twice-daily dosing schedule for nintedanib is more convenient than the dosing schedule for pirfenidone (i.e., three capsules taken three times daily). CDEC noted that patients who are intolerant to pirfenidone could be considered for treatment with nintedanib. Research Gaps: CDEC noted that there is insufficient evidence regarding the following: There are no studies directly comparing nintedanib against pirfenidone for the treatment of patients with IPF. There is no evidence addressing the use of nintedanib in patients who have failed treatment with pirfenidone. CDEC Members: Dr. Lindsay Nicolle (Chair), Dr. James Silvius (Vice-Chair), Dr. Silvia Alessi-Severini, Dr. Ahmed Bayoumi, Dr. Bruce Carleton, Mr. Frank Gavin, Dr. Peter Jamieson, Dr. Anatoly Langer, Mr. Allen Lefebvre, Dr. Kerry Mansell, Dr. Irvin Mayers, Dr. Yvonne Shevchuk, Dr. Adil Virani, and Dr. Harindra Wijeysundera. September 16, 2015 Meeting Regrets: None Notice of Final Recommendation October 15, 2015 Page 6 of 7
7 Conflicts of Interest: None About This Document: CDEC provides formulary listing recommendations or advice to CDR-participating drug plans. CDR clinical and pharmacoeconomic reviews are based on published and unpublished information available up to the time that CDEC deliberated on a review and made a recommendation or issued a record of advice. Patient information submitted by Canadian patient groups is included in the CDR reviews and used in the CDEC deliberations. The manufacturer has reviewed this document and has not requested the removal of confidential information. CADTH has redacted the requested confidential information in accordance with the CDR Confidentiality Guidelines. The CDEC recommendation or record of advice neither takes the place of a medical professional providing care to a particular patient nor is it intended to replace professional advice. CADTH is not legally responsible for any damages arising from the use or misuse of any information contained in or implied by the contents of this document. The statements, conclusions, and views expressed herein do not necessarily represent the view of Health Canada or any provincial, territorial, or federal government or the manufacturer. Notice of Final Recommendation October 15, 2015 Page 7 of 7
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION VEDOLIZUMAB (Entyvio Takeda Canada Inc.) Indication: Crohn s Disease Recommendation: The CADTH Canadian Drug Expert Committee (CDEC) recommends
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION LUMACAFTOR / IVACAFTOR (Orkambi Vertex Pharmaceuticals [Canada] Inc.) Indication: Cystic Fibrosis, F508del-CFTR mutation Recommendation: The CADTH
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION Edoxaban (Lixiana SERVIER Canada Inc.) Indication: Prevention of Stroke and Systemic Embolic Events in Patients With Nonvalvular Atrial Fibrillation
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION TICAGRELOR (Brilinta AstraZeneca Canada Inc.) Indication: Secondary Prevention of Atherothrombotic Events Recommendation: The CADTH Canadian Drug
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION Macitentan (Opsumit Actelion Pharmaceuticals Canada Inc.) Indication: Pulmonary Arterial Hypertension Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION ARIPIPRAZOLE LONG-ACTING INJECTION (Abilify Maintena Otsuka Pharmaceuticals Co. & Lundbeck Canada Inc.) Indication: Schizophrenia Recommendation: The Canadian Drug Expert Committee
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION SACUBITRIL/VALSARTAN (Entresto Novartis Pharmaceuticals) Indication: Heart Failure With Reduced Ejection Fraction Recommendation: The Canadian
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION DACLATASVIR (Daklinza Bristol-Myers Squibb Canada Inc.) Indication: Chronic Hepatitis C Genotype 1, 2, or 3 Infection in Adults Recommendation: The Canadian Drug Expert Committee
More informationFINAL CDEC RECOMMENDATION
FINAL CDEC RECOMMENDATION PALONOSETRON CAPSULE (Aloxi Eisai Limited) Indication: Chemotherapy-Induced Nausea and Vomiting Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that oral
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION INSULIN GLARGINE (Basaglar Eli Lilly Canada) Indications: Type 1 and Type 2 Diabetes Mellitus Recommendation: The CADTH Canadian Drug Expert Committee
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION OMALIZUMAB (Xolair Novartis Pharmaceuticals Canada Inc.) Indication: Chronic Idiopathic Urticaria Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that omalizumab
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION PROPIVERINE HYDROCHLORIDE (Mictoryl/Mictoryl Pediatric Duchesnay Inc.) Indication: Overactive bladder This document was originally issued on April
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION VEDOLIZUMAB (Entyvio Takeda Canada Inc.) Indication: Ulcerative Colitis Recommendation: The CADTH Canadian Drug Expert Committee (CDEC) recommends
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION IXEKIZUMAB (Taltz Eli Lilly Canada Inc.) Indication: Moderate to Severe Plaque Psoriasis Recommendation: The CADTH Canadian Drug Expert Committee
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION ELOSULFASE ALFA RESUBMISSION (Vimizim BioMarin Pharmaceutical (Canada) Inc.) Indication: Mucopolysaccharidosis IVA (Morquio A syndrome) Recommendation:
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE (Genvoya Gilead Sciences Canada, Inc.) Indication: HIV-1 Infection Recommendation:
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION MIRABEGRON (Myrbetriq Astellas Pharma Canada Inc.) Indication: Overactive Bladder Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that mirabegron be listed
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION (FLUTICASONE FUROATE/VILANTEROL) (Breo Ellipta GlaxoSmithKline) Indication: Chronic Obstructive Pulmonary Disease Recommendation: The Canadian Drug Expert Committee (CDEC) recommends
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION PERINDOPRIL ARGININE/AMLODIPINE (Viacoram Servier Canada Inc.) Indication: Mild to Moderate Essential Hypertension Recommendation: The Canadian
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION EVEROLIMUS (Afinitor Novartis Pharmaceuticals Canada) Indication: Renal Angiomyolipoma Associated with Tuberous Sclerosis Complex Recommendation: The Canadian Drug Expert Committee
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION ALEMTUZUMAB (Lemtrada Genzyme Canada) Indication: Relapsing-Remitting Multiple Sclerosis Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that alemtuzumab
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION AFLIBERCEPT (Eylea Bayer Inc.) Indication: Wet Age-related Macular Degeneration Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that aflibercept be listed
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION RANIBIZUMAB (Lucentis Novartis Pharmaceuticals Canada Inc.) New Indication: Macular Edema Secondary to Retinal Vein Occlusion Recommendation: The Canadian Drug Expert Committee
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION TOFACITINIB (Xeljanz Pfizer Canada Inc.) Indication: Rheumatoid Arthritis Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that tofacitinib be listed, in combination
More informationCADTH Canadian Drug Expert Committee Recommendation
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) IVABRADINE HYDROCHLORIDE (LANCORA SERVIER CANADA INC.) Indication: Heart Failure, NYHA class II to III RECOMMENDATION:
More informationFINAL CDEC RECOMMENDATION
FINAL CDEC RECOMMENDATION APIXABAN (Eliquis Bristol-Myers Squibb Canada and Pfizer Canada Inc.) New Indication: Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation Recommendation:
More informationCEDAC FINAL RECOMMENDATION
CEDAC FINAL RECOMMENDATION ROFLUMILAST (Daxas Nycomed Canada Inc.) Indication: Chronic Obstructive Pulmonary Disease Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that
More informationENDATION FINGOLIMOD. Indication: years. a previous. magnetic. relapsing. rate after two. the differences in. annualized. treatment options. in MS.
CDEC FINAL RECOMM ENDATION FINGOLIMOD (Gilenya Novartis Pharmaceuticals Canada Inc.) Indication: Multiple Sclerosis Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that fingolimod
More informationCADTH Canadian Drug Expert Committee Recommendation
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) Lixisenatide (Adlyxine Sanofi-aventis Canada Inc.) Indication: Diabetes mellitus, type 2 Recommendation: The CADTH Canadian
More informationCADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final)
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) BREXPIPRAZOLE (REXULTI LUNDBECK CANADA INC AND OTSUKA CANADA PHARMACEUTICAL Inc.) Indication: Treatment of schizophrenia
More informationCADTH Canadian Drug Expert Committee Recommendation
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) GLECAPREVIR / PIBRENTASVIR (MAVIRET ABBVIE CORPORATION) Indication: Chronic hepatitis C virus infection RECOMMENDATION:
More informationCADTH Canadian Drug Expert Committee Recommendation
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) EMTRICITABINE/RILPIVIRINE/TENOFOVIR ALAFENAMIDE (ODEFSEY GILEAD SCIENCES CANADA INC.) Indication: HIV-1 Infection RECOMMENDATION:
More informationCEDAC FINAL RECOMMENDATION
CEDAC FINAL RECOMMENDATION CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A, FREE FROM COMPLEXING PROTEINS (Xeomin Merz Pharma Canada Ltd.) Indication: Blepharospasm Recommendation: The Canadian Expert Drug Advisory
More informationCADTH Canadian Drug Expert Committee Recommendation
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) APOMORPHINE HYDROCHLORIDE (MOVAPO PALADIN LABS INC.) Indication: Parkinson s disease RECOMMENDATION: The CADTH Canadian
More informationCommon Drug Review Clinical Review Report
Common Drug Review Clinical Review Report October 2015 Drug nintedanib (Ofev) Indication For the treatment of idiopathic pulmonary fibrosis (IPF). Listing request For adult patients who have a diagnosis
More informationCADTH Canadian Drug Expert Committee Recommendation
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (Final) Guselkumab (Tremfya Janssen Inc.) Indication: For the treatment of adult patients with moderate-to-severe plaque psoriasis
More informationAEROSOL. Indication: /formoterol to. older with pressurized. two inhalations
CEDAC FINAL RECOMMENDATION MOMETASONE FUROATE/ FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL (Zenhale Merck Canada Inc.) Indication: Asthma Maintenanc ce (Adults, Children 12 Years or Older) Recommendation:
More informationCADTH Canadian Drug Expert Committee Recommendation
CADTH COMMON DRUG REVIEW CADTH Canadian Drug Expert Committee Recommendation (FINAL) Nusinersen (Spinraza Biogen Canada Inc.) Indication: Treatment of 5q Spinal Muscular Atrophy RECOMMENDATION: The CADTH
More informationCanadian Expert Drug Advisory Committee Final Recommendation Plain Language Version
Canadian Expert Drug Advisory Committee Final Recommendation Plain Language Version MOMETASONE FUROATE/FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL (Zenhale Merck Canada Inc.) Indication: Asthma Maintenance
More informationOFEV MEDIA BACKGROUNDER
OFEV MEDIA BACKGROUNDER 1 What is OFEV (nintedanib*)? 2 How does OFEV (nintedanib*) work? 3 Data overview 4 OFEV (nintedanib*) approval status 1 What is OFEV (nintedanib*)? OFEV (nintedanib*) is a small
More informationNINTEDANIB MEDIA BACKGROUNDER
NINTEDANIB MEDIA BACKGROUNDER 1. What is nintedanib? 2. How does nintedanib work? 3. Data overview 4. International treatment guidelines for IPF 1. What is nintedanib? Nintedanib (OFEV a ) is a small molecule
More informationCanadian Expert Drug Advisory Committee Final Recommendation Plain Language Version
Canadian Expert Drug Advisory Committee Final Recommendation Plain Language Version BUPRENORPHINE TRANSDERMAL PATCH RESUBMISSION (BuTrans Purdue Pharma) Indication: Pain, Persistent (Moderate Intensity)
More informationPRASUGREL HYDROCHLORIDE (Effient Eli Lilly Canada Inc.) Indication: Acute Coronary Syndrome
CEDAC FINAL RECOMMENDATION PRASUGREL HYDROCHLORIDE (Effient Eli Lilly Canada Inc.) Indication: Acute Coronary Syndrome Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that
More informationNintedanib and Pirfenidone: New Medications in the Management of Idiopathic Pulmonary Fibrosis
Nintedanib and Pirfenidone: New Medications in the Management of Idiopathic Pulmonary Fibrosis Brad Zimmermann, PharmD, MBA Pharmacy Grand Rounds May 02, 2017 Rochester, Minnesota 2017 MFMER slide-1 Objectives
More informationCanadian Expert Drug Advisory Committee Final Recommendation Plain Language Version
Canadian Expert Drug Advisory Committee Final Recommendation Plain Language Version LACOSAMIDE (Vimpat UCB Canada Inc.) Indication: Epilepsy, Partial-Onset Seizures Recommendation: The Canadian Expert
More informationCreating Criteria Using Patient Experience for High- Cost & Rare-Use Drugs With Limited Evidence
Creating Criteria Using Patient Experience for High- Cost & Rare-Use Drugs With Limited Evidence Dr. James Silvius Dr. Irvin Mayers Jeremy Slobodan April 25, 2017 Disclosures James L. Silvius No industry
More informationCADTH Optimal use report
Canadian Agency for Drugs and Technologies in Health Agence canadienne des médicaments et des technologies de la santé CADTH Optimal use report Volume 3, Issue 1D July 2013 Optimal Use Recommendations
More informationTracy Ward Highly Specialist Respiratory Nurse Rotherham NHS Foundation Trust
Interstitial Lung Disease (ILD) Tracy Ward Highly Specialist Respiratory Nurse Rotherham NHS Foundation Trust The views expressed in this presentation are those of the speaker and are not necessarily those
More informationTake on IPF progression with OFEV
Every breath matters Take on IPF progression with OFEV Learn more at www.ofev.com IPF=idiopathic pulmonary fibrosis. Please see throughout Understand how IPF affects you Idiopathic pulmonary fibrosis (IPF)
More informationRegulatory Status FDA-approved indication: Ofev is a kinase inhibitor indicated for the treatment of idiopathic pulmonary fibrosis (IPF) (1).
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.45.05 Subject: Ofev Page: 1 of 5 Last Review Date: March 17, 2017 Ofev Description Ofev (nintedanib)
More informationEVIDENCE IN BRIEF OVERALL CLINICAL BENEFIT
differ and that they each has a unique mechanism of action. As such perc considered that it would be important for clinicians and patients to be able to choose either drug as a first-line treatment option.
More informationOfficial ATS/ERS/JRS/ALAT Clinical Practice Guidelines: Treatment of Idiopathic Pulmonary Fibrosis
Official ATS/ERS/JRS/ALAT Clinical Practice Guidelines: Treatment of Idiopathic Pulmonary Fibrosis An Update of the 2011 Clinical Practice Guideline Online Supplement Ganesh Raghu, Bram Rochwerg, Yuan
More informationTherapies for Idiopathic Pulmonary Fibrosis Pharmacologic, Non-Pharmacologic
Therapies for Idiopathic Pulmonary Fibrosis Pharmacologic, Non-Pharmacologic Amy Olson, MD, MSPH Associate Professor, Division of Pulmonary and Critical Care Medicine National Jewish Health, Denver, CO
More informationManagement of Idiopathic Pulmonary Fibrosis
Management of Idiopathic Pulmonary Fibrosis Robert Hallowell, M.D. December 22, 2015 Disclosures No financial disclosures What causes IPF? +? VEGF-R Airspace lining TNFa Fibrocytes PDGF Fibroblasts IL-1
More informationCADTH COMMON DRUG REVIEW Pharmacoeconomic Review Report
CADTH COMMON DRUG REVIEW Pharmacoeconomic Review Report Netupitant/Palonosetron 300 mg/0.5 mg (Akynzeo) (Purdue Pharma) Indication: In combination with dexamethasone, once-percycle treatment for the prevention
More informationExperience with the Compassionate Use Program of nintedanib for the treatment of Idiopathic Pulmonary Fibrosis in Argentina
ORIGINAL 131 RAMR 2017;2:131-135 ISSN 1852-236X Correspondence Gabriela Tabaj gabrielatabaj@gmail.com Received: 11.15.2016 Accepted: 02.03.2017 Experience with the Compassionate Use Program of nintedanib
More informationUpdate on Therapies for Idiopathic Pulmonary Fibrosis. Outline
Update on Therapies for Idiopathic Pulmonary Fibrosis Paul Wolters Associate Professor University of California, San Francisco Outline Classification of Interstitial lung disease Clinical classification
More informationCommon Drug Review Pharmacoeconomic Review Report
Common Drug Review Pharmacoeconomic Review Report November 2016 Drug Indication ustekinumab (Stelara) Injection The treatment of adult patients with active psoriatic arthritis alone or in combination with
More informationEVIDENCE IN BRIEF OVERALL CLINICAL BENEFIT
into consideration the concerns of the patient. Upon reconsideration of the perc Initial Recommendation,the Committee discussed feedback from the patient advocacy group reporting concerns that the definition
More informationEVIDENCE IN BRIEF OVERALL CLINICAL BENEFIT
Overall, perc considered that everolimus aligned with patient values. Patient advocacy group input on everolimus indicated that patients with pnets value the outcome of progression-free survival as a measure
More informationOVERALL CLINICAL BENEFIT
noted that there are case reports of a rebound effect upon discontinuation of ruxolitinib (Tefferi 2012), although this was not observed in either the COMFORT I or COMFORT II studies. Therefore, perc considered
More informationroflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd
roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd 06 August 2010 (Issued 10 September 2010) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationaclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A.
aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A. 05 October 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and
More informationDisclosures. IPF Medications: Practical Experience. Prednisone, Azathioprine, N acyetylcysteine. Case 1. Brett Ley, MD, MAS Assistant Professor, UCSF
IPF Medications: Practical Experience Disclosures Received speakers bureau honorarium from Roche/Genentech (makers of pirfenidone). Brett Ley, MD, MAS Assistant Professor, UCSF 67 y/o man 1 year cough
More informationPatient Input CADTH COMMON DRUG REVIEW. MEPOLIZUMAB (Nucala) (GlaxoSmithKline Inc.) Indication: asthma, severe eosinophilic
CADTH COMMON DRUG REVIEW Patient Input MEPOLIZUMAB (Nucala) (GlaxoSmithKline Inc.) Indication: asthma, severe eosinophilic CADTH received patient input from: Asthma Canada The Ontario Lung Association
More informationBackground 1. Comparative effectiveness of nintedanib
NCPE report on the cost effectiveness of nintedanib (Vargatef ) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung
More informationOFEV Frequently Asked Questions (FAQs)
OFEV Frequently Asked Questions (FAQs) INDICATION AND USAGE OFEV is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). WARNINGS AND PRECAUTIONS Hepatic Impairment OFEV is not recommended
More informationKD : A Phase 2 Trial of KD025 to Assess Safety, Efficacy and Tolerability in Patients with Idiopathic Pulmonary Fibrosis (IPF)
-207: A Phase 2 Trial of to Assess Safety, Efficacy and Tolerability in Patients with Idiopathic Pulmonary Fibrosis (IPF) K. F. Gibson 1, F. Averill 2, T.E. Albertson 3, D. M. Baratz 4, S. Chaudhary 5,
More informationumeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline
umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline 07 November 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationStudy population The study population comprised a hypothetical cohort of poorly reversible COPD patients with a history of exacerbations.
Development of an economic model to assess the cost-effectiveness of treatment interventions for chronic obstructive pulmonary disease Spencer M, Briggs A H, Grossman R F, Rance L Record Status This is
More informationrisks. Therefore, perc agreed that the reimbursement criteria should match the eligibility criteria of the SELECT trial.
risks. Therefore, perc agreed that the reimbursement criteria should match the eligibility criteria of the SELECT trial. perc considered input from one patient advocacy group indicating that patients value
More informationCommon Drug Review Patient Group Input Submissions
Common Drug Review Patient Group Input Submissions nintedanib (Ofev) for Idiopathic pulmonary fibrosis (IPF) Patient group input submissions were received from the following patient groups. Those with
More informationNew Horizons The Future of IPF and ILD
New Horizons The Future of IPF and ILD Talmadge E. King, Jr., M.D. Julius R. Krevans Distinguished Professorship in Internal Medicine Chair, Department of Medicine University of California San Francisco
More informationGLPG1690 FLORA topline results
GLPG1690 FLORA topline results Webcast presentation 10 August 2017 Disclaimer This presentation contains forward-looking statements, including (without limitation) statements concerning the potential activity
More informationCOPD. Helen Suen & Lexi Smith
COPD Helen Suen & Lexi Smith What is COPD? Chronic obstructive pulmonary disease: a non reversible, long term lung disease Characterized by progressively limited airflow and an inability to perform full
More informationCost-Effectiveness of Therapy with Combinations of Long-Acting Bronchodilators and Inhaled Steroids for Treatment of COPD
Collaboration for Outcomes Research and Evaluation University of British Columbia Cost-Effectiveness of Therapy with Combinations of Long-Acting Bronchodilators and Inhaled Steroids for Treatment of COPD
More informationDronedarone for the treatment of non-permanent atrial fibrillation
Dronedarone for the treatment of non-permanent atrial Issued: August 2010 last modified: December 2012 guidance.nice.org.uk/ta197 NICE has accredited the process used by the Centre for Health Technology
More informationClinical Review Report (Sample)
CADTH COMMON DRUG REVIEW Clinical Review Report (Sample) GENERIC DRUG NAME (BRAND NAME) (Manufacturer) Indication: Text Disclaimer: The information in this document is intended to help Canadian health
More informationlimitations of the indirect evidence submitted to pcodr, perc concluded that there is considerable uncertainty on how alectinib compares with ceritinib with regard to outcomes important to decision making
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Idiopathic Pulmonary Fibrosis Page 1 of 10 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Idiopathic Pulmonary Fibrosis (Esbriet /pirfenidone, Ofev /nintedanib)
More informationEmerging Therapies for Lung Fibrosis. Helen Garthwaite Respiratory Registrar/ Clinical Research Fellow
Emerging Therapies for Lung Fibrosis Helen Garthwaite Respiratory Registrar/ Clinical Research Fellow Lung Fibrosis/Interstitial Lung Disease Disease that affects the tissue that supports the lungs alveoli
More informationglycopyrronium 44 micrograms hard capsules of inhalation powder (Seebri Breezhaler ) SMC No. (829/12) Novartis Pharmaceuticals Ltd.
glycopyrronium 44 micrograms hard capsules of inhalation powder (Seebri Breezhaler ) SMC No. (829/12) Novartis Pharmaceuticals Ltd. 07 December 2012 The Scottish Medicines Consortium (SMC) has completed
More informationThe pcodr review also provided contextual information on ALK mutation testing.
only approximately 4% of NSCLC patients are expected to have the ALK mutation. perc further discussed these estimates in the context of the feasibility of implementing a funding recommendation for crizotinib.
More informationRoflumilast (Daxas) for chronic obstructive pulmonary disease
Roflumilast (Daxas) for chronic obstructive pulmonary disease August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended
More informationSummary: Key Learning Points, Clinical Strategies, and Future Directions
Summary: Key Learning Points, Clinical Strategies, and Future Directions Introduction Idiopathic pulmonary fibrosis (IPF), a peripheral lobular fibrosis of unknown cause, is a chronic, progressive lung
More informationIPF AND OTHER FIBROSING LUNG DISEASE: WHAT DRUGS MIGHT WORK AND ON WHOM DO THEY W ORK?
IPF AND OTHER FIBROSING LUNG DISEASE: WHAT DRUGS MIGHT WORK AND ON WHOM DO THEY W ORK? KEVIN K. BROWN, MD PROFESSOR AND VICE CHAIRMAN, DEPARTMENT OF MEDICINE NATIONAL JEWISH HEALTH DENVER, CO Kevin K.
More informationCommon Drug Review Pharmacoeconomic Review Report
Common Drug Review Pharmacoeconomic Review Report October 2014 Drug Sofosbuvir (Sovaldi) (400 mg/tablet) Indication Sofosbuvir is indicated for the treatment of chronic hepatitis C virus (CHC) infection
More informationEvaluating New Treatment Options
Evaluating New Treatment Options Steven D. Nathan, MD Clinical Practice Guideline Changes 211 ATS/ERS/JRS/ALAT Recommendations Treatment of IPF combines nonpharmacologic and pharmacologic strategies, and
More informationCost-effectiveness of nivolumab with ipilimumab (Opdivo with Yervoy ) for the treatment of advanced (unresectable or metastatic) melanoma.
Cost-effectiveness of nivolumab with ipilimumab (Opdivo with Yervoy ) for the treatment of advanced (unresectable or metastatic) melanoma. The National Centre for Pharmacoeconomics (NCPE) has issued a
More informationControversies in Clinical Trials. Pirfenidone for Idiopathic Pulmonary Fibrosis (IPF)
Controversies in Clinical Trials Pirfenidone for Idiopathic Pulmonary Fibrosis (IPF) Controversies to be highlighted by IPF Post-hoc analyses Story Primary end point selection Changing prespecified endpoints
More informationCost-effectiveness of osimertinib (Tagrisso )
Cost-effectiveness of osimertinib (Tagrisso ) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung
More informationpcodr EXPERT REVIEW COMMITTEE (perc) FINAL RECOMMENDATION
pcodr EXPERT REVIEW COMMITTEE (perc) FINAL RECOMMENDATION The pan-canadian Oncology Drug Review (pcodr) was established by Canada s provincial and territorial Ministries of Health (with the exception of
More information1. Comparative effectiveness of vedolizumab
Cost-effectiveness of vedolizumab (Entyvio ) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were
More informationInterstitial Lung Disease
Interstitial Lung Disease Interstitial lung disease (ILD) is a broad category of lung diseases that includes more than 130 disorders which are characterized by scarring (i.e. fibrosis ) and/or inflammation
More informationJOINT CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) MANAGEMENT GUIDELINES
JOINT CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) MANAGEMENT GUIDELINES Authors Dr Ian Benton Respiratory Consultant COCH Penny Rideal Respiratory Nurse COCH Kirti Burgul Respiratory Pharmacist COCH Pam
More informationInterstitial Lung Disease
Interstitial Lung Disease Interstitial lung disease (ILD) is a broad category of lung diseases that includes more than 130 disorders which are characterized by scarring (i.e. fibrosis ) and/or inflammation
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationCost-effectiveness of Ivacaftor (Kalydeco ) for the treatment of cystic fibrosis in patients age 6 years and older who have the G551D mutation
Cost-effectiveness of Ivacaftor (Kalydeco ) for the treatment of cystic fibrosis in patients age 6 years and older who have the G551D mutation January 2013 1. A rapid review submission on the drug ivacaftor
More informationPresente e futuro della terapia della fibrosi polmonare idiopatica
Presente e futuro della terapia della fibrosi polmonare idiopatica Antonella Caminati U.O. di Pneumologia e Terapia Semi Intensiva Servizio di Fisiopatologia Respiratoria ed Emodinamica Polmonare Osp.
More informationmidostaurin should be extended to patients who are deemed fit to receive intensive induction and consolidation, regardless of age.
midostaurin should be extended to patients who are deemed fit to receive intensive induction and consolidation, regardless of age. perc deliberated on the toxicity profile of midostaurin and noted that
More information